Class II — Northeast Scientific Inc.
| Recalling firm | NORTHEAST SCIENTIFIC, INC. |
|---|---|
| Registered facility | NORTHEAST SCIENTIFIC, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles. |
| Product | NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901 |
| Quantity | 690 devices |
| Distribution | US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX. |
| Initiated | 2021-04-26 |
| Classified | 2021-08-23 |
| Terminated | 2022-03-09 |
| Recall number | Z-2334-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Northeast Scientific Inc. (Z-2334-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88345/
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